System and method for remote colorimetry and ratiometric comparison and quantification in analysis of medical test results

ABSTRACT

A system for providing colorimetric and ratiometric comparison and quantification for medical test results, comprising a testing device including an alignment target and including a plurality of immunoassay test strips, the plurality of immunoassay test strips each including a test line and a control line, and a colorimetry device configured to operate with a mobile device, the mobile device including a camera and a software application stored thereon, wherein the software application provides executable instructions to detect color properties of a color of the test line and a color of a control line of at least one of the plurality of immunoassay test strips, determine a risk value for each of at least one disease risks tested using the biologic sample, wherein the risk value is a rating determined from the color properties of the color of the test line, and provide medical test results based on the risk value.

TECHNICAL FIELD

The following disclosure is related to a system and method forinitiating a telemedicine conference in response to diagnostic testresults.

SUMMARY

A system for providing colorimetric and ratiometric comparison andquantification for medical test results is provided. The systemcomprises a testing device including thereon an alignment target andincluding a plurality of immunoassay test strips, the plurality ofimmunoassay test strips each including a sample pad capable of receivinga biologic sample, a conjugate pad containing particles for conjugatingwith antibodies or antigens present in the biologic sample, and amembrane strip including a test line and a control line, wherein thetest line and the control line are viewable, a colorimetry deviceconfigured to operate with a mobile device, the mobile device includinga camera, a viewing screen, and a software application stored thereon,wherein the software application provides executable instructions toreceive a test selection, issue a notification concerning use of thecolorimetry device and instructions regarding configuration of thecolorimetry device, initiate operation of the camera of the mobiledevice, present on the viewing screen of the mobile device an alignmentgraphic to be aligned with the alignment target of the testing device,detect when an alignment of the alignment graphic and the alignmenttarget has taken place, capture an image of the testing device inresponse to detecting the alignment of the alignment graphic and thealignment target, detect color properties of a color of the test lineand a color of a control line of at least one of the plurality ofimmunoassay test strips, transmit the image and color properties to aserver, determine a risk value for each of at least one disease riskstested using the biologic sample, wherein the risk value is a ratingdetermined from the color properties of the color of the test line, andprovide medical test results based on the risk value.

A method for providing colorimetric and ratiometric comparison andquantification for medical test results is provided. The methodcomprises collecting at least one biologic sample by a testing deviceincluding thereon an alignment target and including a plurality ofimmunoassay test strips, conjugating the at least one biologic samplewith particles on a conjugate pad on at least one of the plurality ofimmunoassay test strips to create an immune complex, binding antigens orantibodies of the immune complex to antigens or antibodies of a testline of at least one of the plurality of immunoassay test strips,providing a software application to be stored on a mobile device, themobile device including a camera and a viewing screen, providing acolorimetry device configured to operate with the mobile device,receiving a test selection via the software application, issuing by thesoftware application a notification concerning use of the colorimetrydevice and instructions regarding configuration of the colorimetrydevice, initiating operation of the camera, presenting on the viewingscreen an alignment graphic to be aligned with the alignment target ofthe testing device, detecting when an alignment of the alignment graphicand the alignment target has taken place, capturing an image of thetesting device in response to detecting the alignment of the alignmentgraphic and the alignment target, detecting color properties of a colorof the test line and a color of a control line of at least one of theplurality of immunoassay test strips, transmitting the image and colorproperties to a server, determining a risk value for each of at leastone disease risks tested using the biologic sample, wherein the riskvalue is a rating determined from the color properties of the color ofthe test line, and providing medical test results based on the riskvalue.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding, reference is now made to thefollowing description taken in conjunction with the accompanyingDrawings in which:

FIG. 1 illustrates a diagrammatic representation of one embodiment of aimmunoassay test strip;

FIG. 2 illustrates a diagrammatic representation of one embodiment of animmunoassay test wherein an analyte is tested across a plurality of teststrips;

FIG. 3 illustrates a diagrammatic representation of one embodiment of atesting device;

FIG. 4 illustrates a top view of the testing device of FIG. 3;

FIG. 5 illustrates a top view of one embodiment of a testing device;

FIG. 6 illustrates a top view of another embodiment of a testing device;

FIG. 7 illustrates a flowchart of one embodiment of a testing device usemethod;

FIG. 8A illustrates a diagrammatic representation of one embodiment of aprocess for a mobile device application for testing device image captureand image processing, wherein an image alignment indicator is notaligned with the subject of the image;

FIG. 8B illustrates a diagrammatic representation of one embodiment of aprocess for a mobile device application for testing device image captureand image processing, wherein an image alignment indicator is alignedwith the subject of the image;

FIG. 9 illustrates a flowchart of one embodiment of an image analysisprocess using a mobile device;

FIG. 10 illustrates a diagrammatic representation of another embodimentof a process for a mobile device application for testing device imagecapture and image processing, wherein an image alignment indicator isaligned with the subject of the image;

FIG. 11 illustrates one embodiment of a consumer driven biologic anddisease data collection system;

FIG. 12 illustrates one embodiment of a consumer driven biologic anddisease data collection system;

FIG. 13 illustrates an example of a unique biologic ID database table;

FIG. 14 illustrates a flowchart of one embodiment of a biologic datacollection and dissemination process;

FIG. 15 illustrates a perspective view of a system for scanning teststrips;

FIG. 16 illustrates a cross-sectional view of the system of FIG. 15;

FIG. 17 illustrates one embodiment of a vertical flow immunoassaydevice;

FIG. 18 illustrates a cross-sectional view of one embodiment of thevertical immunoassay device of FIG. 17;

FIG. 19 illustrates a color gradient chart;

FIG. 20 illustrates a normalized past tests results rating chart;

FIG. 21 illustrates a mobile device displaying on a screen a mobileapplication variable test functionality;

FIG. 22 illustrates the mobile device of FIG. 21, wherein a housing of atesting device also includes thereon test function indicators;

FIG. 23 illustrates one embodiment of a medical code correlation system;

FIG. 24 illustrates one embodiment of a strep home retail test codestable;

FIG. 25 illustrates one embodiment of a combined pregnancy and Zika homeretail test codes table;

FIG. 26 illustrates flowchart of one embodiment of a medical codecorrelation process;

FIG. 27 illustrates one embodiment of a telemedicine initiation optionwithin a mobile application;

FIG. 28 illustrates another embodiment of a telemedicine initiationoption within a mobile application;

FIG. 29 illustrates one embodiment of a telemedicine conference sessionon a mobile device;

FIG. 30 illustrates a flowchart of one embodiment of a medical filehandoff process;

FIG. 31 illustrates a flowchart of one embodiment of a telemedicineconference initiation process;

FIG. 32 illustrates an attachable lighting apparatus;

FIG. 33 illustrates a light spectrum apparatus;

FIG. 34 illustrates an attachable color filter apparatus;

FIG. 35 illustrates a mobile device with a colorimetry device coupledthereto;

FIG. 36 illustrates a mobile device with a colorimetry device coupledthereto

FIG. 37 illustrates a mobile device coupled to a colorimetry device viaa charging port of the mobile device;

FIG. 38A illustrates a top view of a light box apparatus;

FIG. 38B illustrates a top perspective view of a light box apparatus;

FIG. 38C illustrates a top view of a light box apparatus in an openstate;

FIG. 38D illustrates a side cross sectional view of a light boxapparatus;

FIG. 39 illustrates a light box apparatus including a plurality oflights in an alternate configuration;

FIG. 40 illustrates a color wavelength detection arrangement;

FIG. 41 illustrates a color wavelength detection arrangement;

FIG. 42 illustrates a flowchart of a mobile device colorimetry analysisprocess;

FIG. 43 illustrates an immunoassay test strip including fluorescent dyeindicators;

FIG. 44A illustrates a chart showing wavelength and fluorescenceintensity of free and bound subjects according to non-ratiometricmethods;

FIG. 44B illustrates a comparison of a free and a bound subjectaccording to non-ratiometric methods;

FIG. 45A illustrates a chart showing wavelength and fluorescenceintensity of free and bound subjects according to ratiometric methods;

FIG. 45B illustrates a comparison of a free and a bound subjectaccording to ratiometric methods;

FIG. 45C illustrates a chart showing a ratio applied to fluorescenceintensity of free and bound subjects; and

FIG. 46 illustrates a diagrammatic view of one embodiment of a systemdevice that may be used within the environment described herein

DETAILED DESCRIPTION

Referring now to the drawings, wherein like reference numbers are usedherein to designate like elements throughout, the various views andembodiments of an arbovirus indicative birth defect risk test areillustrated and described, and other possible embodiments are described.The figures are not necessarily drawn to scale, and in some instancesthe drawings have been exaggerated and/or simplified in places forillustrative purposes only. One of ordinary skill in the art willappreciate the many possible applications and variations based on thefollowing examples of possible embodiments.

Referring now to FIG. 1, there is illustrated one embodiment of animmunoassay test strip 100. The test strip 100 is typically housed in atesting device configured to collect a biologic analyte 106 from a userand to direct to the biologic analyte 106 onto the testing strip 100.However, it will be understood that the biologic may be applied onto astrip 100 without the strip 100 needing to be within a testing device.The test strip 100 includes a backing 102. The test strip 100 is made upof multiple sections disposed on the backing 102. A sample pad 104 isdisposed on one end of the strip 100, for collecting the biologicanalyte 106. The biologic analyte 106 may be any biologic needed for usein the immunoassay, such as urine, blood, saliva, stool, sweat, or otherbiologics to be used as an analyte. Various methods may be used toacquire the needed biologic, and such may be provided to the userpackaged with the test, such as swabs, vials, containers, dilutants andother solutions, or any other equipment required. In the case of a bloodanalyte, a few drops of blood may be obtained from a finger stick usinga finger prick device. Such a blood analyte may be blood mixed with anadequate amount of buffered solution to create the sample analyte 106 ora blood sample that is not diluted or otherwise manipulated, in whichcase the blood only is the analyte 106.

The biologic analyte 106, after coming into contact with the sample pad104, begins to migrate across the strip 100 by capillary action, cominginto contact with other sections of the strip 100. A particle conjugatepad 108 is disposed between the sample pad 104 and a test line 110. Theconjugate pad 108 may contain various reagents associated with aparticular antigen, such as a virus, allergen, or bacteria, the reagentsbeing items such antibodies, enzymes, or other reagents needed todiagnose the particular condition. The reagent in the conjugate pad 108may be conjugated with particles of materials such as colloid gold orcolored latex beads. As the analyte 106 migrates through the conjugatepad 108, antibodies present in the sample analyte 106 complex with thereagents in the conjugate pad 108, thereby creating an immune complexthat will migrate to the test zone or test line 110.

The test line 110 (T) may be precoated with the relevant antigen inquestion, i.e., a virus, allergen, or bacteria, for the detection ofantibodies associated with the particular antigen. The immune complexcreated when the analyte 106 passes through the conjugate pad 108 iscaptured onto the antigen contained on the test line 110. This maycreate a qualitative response on the strip where the test line 110 islocated, such as a colored response. In some embodiments, the test line110 may not be a line, but may be other shapes or symbols, such as aplus sign. If no antigen-anti-antigen complexes are present in theanalyte, no reaction occurs in the test line 110 and a qualitativeresponse will not occur.

After passing through the test line 110, the analyte migrates furtheralong the strip to reach a control line 112, where excessanti-antibody-colloidal gold or latex conjugates get bound. Aqualitative response may be shown at the control line 112, indicatingthat the sample has adequately migrated across the testing membrane orsubstrate as intended. It will be understood that the control line 112is not necessarily needed to perform the test, and may be eliminatedentirely, but the control line 112 does provide a comparative examplefor a user reading the test. For example, the control line 112, inembodiments where a colored qualitative response is provided, may appearas an overly saturated color, such as a dark or bright saturated red,once the sample reaches the control line 112. This saturated color maybe used as a comparison against the qualitative response shown on thetest line 110. For example, if the qualitative response shown on thetest line 110 is a much lighter red than that on the test line 110, itmay be that very little reaction occurred at the test line. Of course,if no response is shown at all at the test line 110, no reaction hasoccurred. If the qualitative response at the test line 110 is of asimilar saturation to the control line 112, a strong reaction isindicated.

The strip 100 may not be a continuous substrate. Rather, the varioussections of the strip 100 may be separate from each other, but alladhered to the backing 102. As shown in FIG. 1, the sample pad 104 andthe conjugate pad 108 are separate structures from each other. The testline 110 or zone and the control line 112 or zone are both disposed aspart of a nitrocellulose membrane strip 114. The nitrocellulose membranestrip 114 is also adhered to the backing 102, but separate from thesample pad 104 and the conjugate pad 108. As shown in FIG. 1, the end ofthe sample pad 104 adjacent to the conjugate pad 108 may overlap theconjugate pad 108, with that end of the sample pad 106 lying over theadjacent end of the conjugate pad 108. Similarly, the end of theconjugate pad adjacent to the nitrocellulose membrane strip 114 may lieover the end of the nitrocellulose membrane adjacent to the conjugatepad. This allows for the analyte 106 to be more easily deposited ontoeach section of the strip 100 as it migrates across the strip 100. Afterthe analyte 106 migrates across the nitrocellulose membrane strip 114,and thus across the test line 110 and the control line 112, the analyte106 comes into contact with a wick 116 for absorbtion and collection ofthe analyte 106. The end of the wick 116 adjacent to the nitrocellulosemembrane strip 114 may lie over that adjacent end of the nitrocellulosemembrane strip 114, as shown in FIG. 1.

Several Flow Immune Assays have been directed toward identifyingproteins, molecules of interest, and even immunoglobulins IgG, IgA, andIgM. IgE is an antibody (immunoglobulin E) that is normally present inthe blood freely circulating until it moves into the tissue where it isbound to mast cells through the receptor FcERI (F-C-epsilon-R-one)otherwise known as the high affinity IgE receptor. There is a smallamount of IgE bound to IgE receptors (high and low affinity receptors)on basophils, eosinophils, and other cells in the blood and tissues.

Many assay systems are geared toward the detection of infectiousproteins. All of the aforementioned tests use a non-humanantibody—usually IgG type—e.g., goat IgG antibody directed against aprotein of interest to detect the protein of interest from the sample(blood, urine, saliva, sweat, etc.). This antibody complexes withprotein of interest and forms a complex that travels across the membraneuntil it reaches the test zone. In the test zone there is an IgG typeantibody directed against IgG from that species of animal. As furtherdescribed herein, the present detecting apparatus and method use human(patient/consumer-derived) antibodies from the sample and the test zonethat contains a humanized antibody directed against the protein ofinterest that is preconjugated to a detecting substance that results ina visual change.

Summary of Target Antigen:

-   -   The target antigens may be proteins, glycoproteins, lipoproteins        or other molecular substances capable of eliciting an immune        reaction and/or being bound by human specific IgE (sIgE).

Immune Assay to Detect Specific IgE:

-   -   In the detecting apparatus and method of using the same, the        antigens are proteins conjugated to a noble metal, for example,        gold, or latex conjugated to antigen in the test zone, for the        purpose of detecting the presence of specific IgE (e.g.,        anti-peanut IgE in a blood sample from a finger prick). For        example, an IgG class antibody (IgG1, IgG2, IgG3, or IgG4) or        fragments of those classes of antibodies (fab fragments) whose        origin may be any animal species (goat, rat, human, etc.)        capable of detecting human IgE (anti-IgE IgG)—a suitable        commercially available humanized antibody, such as omaluzimab        may be used—may be used to form immune complexes of        IgG-anti-IgE-sIgE that will migrate to the test zone having        selected specific IgE that can bind to the conjugated antigen.

Immune assay to detect total IgE (not concerned about specific IgE):

-   -   Another embodiment includes using an IgG class antibody (IgG1,        IgG2, IgG3, or IgG4) or fragments of those classes of antibodies        (fab fragments) whose origin may be any animal species (goat,        rat, human, etc.) capable of detecting human IgE (anti-IgE        IgG)—a suitable commercially available humanized antibody that        is preconjugated to a detecting molecule that results in a color        change when bound to IgE as the target antigen in the test zone.

Referring now to FIG. 2, there is illustrated one embodiment of animmunoassay test 200 wherein an analyte 202 is tested across a pluralityof test strips 204. The plurality of test strips 204 may each beconfigured for testing for a particular antigen. For instance, one stripmay be for testing for the presence of streptococcal bacteria (strepthroat), one strip may be for testing for a peanut allergy, one stripmay be for testing for the Zika virus, etc. Additionally, each strip mayalso test for multiple antigens. For example, as shown in FIG. 2,multiple testing panels or lines maybe be incorporated. Each line may befor a particular antigen. As shown in FIG. 2, multiple test lines 206,208, and 208 may be disposed along the plurality of strips 204. A striptesting for allergens may have a panel for testing for peanut allergiesshown at test line 206 (CH1), for cat allergies shown at test line 208(CH2), or grass allergies shown at test line 210 (CH3).

Other examples of configurations for the testing panels can be, but arenot limited to: 1) Food 5: Peanut, milk, soy, wheat, egg; 2) Nut andseed panel: almond, cashew, hazelnut, peanut, pecan, walnut, sesameseed, sunflower seed; 3) seafood: crab, lobster, shrimp, salmon, tuna;4) Pets: cat, dog; 5) Indoor allergens: dust mites, mold mix(alternaria, aspergillus, penicillium, cladosporium), cat, dog; and 6)seasonal allergens: grass (Bermuda, bahia, Johnson, rye, timothy), trees(oak, elm, cedar, mesquite, pine, etc.), weeds (pigweed, ragweed, sage,Russian thistle).

With respect to other non-allergen antigens, the panels may be fortesting for strep, Zika, flu, anthrax, cold viruses, cancer, HPV, Lymedisease, mononucleosis (mono), and other illnesses, and/or otherconditions such as pregnancy (hCG detection) and disease risks. Someembodiments may allow for the testing of various arboviruses(arthropod-borne viruses). Arboviruses are viruses that are transmittedby arthropods, with mosquitos being a common vector for the virus.Vectors are organisms that transfer the virus from a host that carriesthe virus. Thus, in the case of mosquitos, a mosquito that feeds on ahost that is infected with a virus may infect others when that mosquitoagain feeds on an uninfected host. Well-known arboviruses include Denguevirus, Japanese encephalitis virus, Rift Valley fever virus, West Nilevirus, yellow fever virus, chikungunya, and Zika virus. Urine, blood,and saliva and other biologics may be used for arboviruses testing.

Certain antigens or medical conditions may be logically paired together.For instance, a testing device may include both a strip for detection ofpregnancy and a strip for the detection of the zika virus, as the Zikavirus has been known to cause birth defects in infants born to pregnantwomen that are infected with Zika. Thus, combining these two tests intoa single testing device or kit would alert a woman to a potential Zikainfection proximate in time to the time she also discovers she ispregnant, allowing the woman to seek medical attention immediately. Thisis a substantial improvement over past Zika testing, where a woman maybe required to wait weeks before results are returned from a lab afterhaving the biologic collected by her physician. In many cases, this maylead to a woman having passed a state-mandated cutoff point forabortions, such as 24 weeks in some states. Combining a Zika test with apregnancy test and physically linking the two tests, and thus allowingfor a woman to determine a Zika risk at the time of taking a pregnancytest, in which a pregnancy test may be taken as soon as six days afterconception, allows for that woman to take action much sooner than thestate mandated cutoff and waiting for lab results would allow.

Various testing devices that include the test strip 100 or strips may beused, such as a slide that supports the test strip 100, a cassette baseddiagnostic test, a dipstick, or combinations thereof. The test resultsin various embodiments may be in the form of a visual qualitativereading test, a visual semiquantitative format, a reader quantitativeassay format, and/or combinations thereof. Additionally, an electronicimplementation may be used where the result is displayed digitally on ascreen disposed within the apparatus, and visible to the user.

The apparatus and method of detection may be a “one-step” approach fromsample to reading without sample dilution or other sample manipulation.The sample may be diluted or endure other sample manipulation, forexample the blood sample is diluted with a buffer.

Referring now to FIG. 3, there is illustrated a diagrammaticrepresentation of one embodiment of a testing device 300. The testingdevice 300 includes a housing 302 that forms the body of the testingdevice. The housing 302 may be made of plastic, metal, or any materialdurable enough for shipping and subsequent handling by a user. Thehousing 302 may be hollow so that a plurality of test strips 304 may behoused within and so that a biologic may be deposited within the housing302. The testing device 300 may further have a plurality of windows 306,each window being associated with one of the plurality of test strips304, and allowing for a user to view at least the section of thenitrocellulose membrane strip 114 where the test line 110 and controlline 112 are located. The plurality of windows 306 may be open, orcovered with plastic, glass, or other materials that allow for viewingthe plurality of strips 304. A sample well 308 may be disposed on asurface of the housing 302 to allow a user to deposit a biologic intothe housing 302. The sample well 308 would be disposed over or near thesample pad 104 of the test strip or strips 100. In the embodiment shownin FIG. 3, a single sample well 308 is included for collection of asingle type of biologic for testing, with each of the plurality ofstrips 304 being suited for testing for antigens using that particularbiologic sample type. For example, if the testing device 300 is acombined pregnancy and Zika test, having both a pregnancy strip and aZika strip, a urine sample may be deposited into the sample well 308,causing the urine sample to come into contact with the sample pad 104 onboth the pregnancy strip and the Zika strip. It will be understood thatboth of these tests may also be performed with a blood sample.

The testing device 300 may also have disposed on the surface of thehousing a crosshair symbol 310, used as an alignment target. This symbolmay be a graphic printed or adhered to the testing device 300. Thecrosshair symbol 310 is used to align the testing device 300 for thetaking of an image of the testing device 300 using a camera on a mobiledevice, for use in a mobile device application described herein. Inother embodiments, the crosshair symbol 310 may be other types ofsymbols, such as a simple shape (circle, square, etc.), other images(such as a medical cross symbol, an arrow, etc.), or any other type ofimage.

Referring now to FIG. 4, there is illustrated a top view of the testingdevice 300. There is again shown the housing 302, the plurality of teststrips 304, the plurality of windows 306, the sample well 308, and thecrosshair symbol 310.

Referring now to FIG. 5, there is illustrated a top view of oneembodiment of a testing device 500. The testing device 500 includes ahousing 502 having a plurality of test strips 504 within the housing 502and a plurality of windows 506 for display of the plurality of strips504. The housing 502 also includes a plurality of sample wells 508disposed on one side of the testing device 500. Each of the plurality ofsample wells 508 is associated with one of the plurality of test strips504 and each of the plurality of sample wells 508 may be disposed overone of the sample pads 104 on the associated one of the plurality oftest strips 504. This allows for a biologic to be deposited into each ofthe plurality of sample wells 508, with each well 508 serving totransfer the biologic to the test strip underneath the sample well. Thetesting device 500 further includes a crosshair 510. The crosshairsymbol 510 is used to align the testing device 500 for the taking of animage of the testing device 500 using a camera on a mobile device, foruse in a mobile device application described herein.

Referring now to FIG. 6, there is illustrated a top view of anotherembodiment of a testing device 600. The testing device 600 includes ahousing 602 having a plurality of test strips 604 within the housing 602and a plurality of windows 606 for display of the plurality of strips604. The housing 602 also includes a plurality of sample wells 608. Inthis embodiment, the sample wells are located on different ends of thehousing 602. In the case of a two test strip device, the sample wells608 are disposed on opposite ends of the testing device 600. The strips604 would be arranged within the housing in such a way as to allow thesample pad 104 on each of the strip to be disposed underneath one of thesample wells 608. This is useful for testing devices that requiredifferent biological samples. For example, if the testing device 600required a urine sample for one strip and a blood sample for the otherstrip, having the wells 608 disposed on opposite sides of the testingdevice would reduce the likelihood that a urine sample, for instance,might be inadvertently deposited into the well designated for the bloodsample. In embodiments where there are more than two strips, and morethan two wells, the well positions may alternate between the two sidesof the testing device. For instance, a first well for a first stripmight be disposed on the left side of the testing device, a second wellfor a second strip might be disposed on the right side of the testingdevice, a third well for a third strip might be disposed on the leftside of the testing device, a fourth well for a fourth strip might bedisposed on the right side of the testing device, and so on. The testingdevice 600 further includes a crosshair 610. The crosshair symbol 610 isused to align the testing device 600 for the taking of an image of thetesting device 600 using a camera on a mobile device, for use in amobile device application described herein.

The diagnostic test can, for example, be produced in a various formatsfor different users, such as, but not limited to, consumer/in-home usewhere the test is purchased through retail channels which will allowindividuals to get an immediate, cost-effective test result that canlead to specific avoidance and treatment through follow-up with amedical professional.

The diagnostic test can be provided to and used by hospitals and clinicsto provide rapid, on-site test results that are required to prescribecertain medications, such as omaluzimab, by their FDA labels.

This diagnostic assay can be modified to detect the presence of specificIgE in pets.

It is also noted that housing 602 is designed such that both strips 604are disposed in physical proximity thereto and in the same actualhousing. In this manner, both sets are linked physically to each othersuch that they cannot be separated and can be associated with a singleindividual and the actual test cannot be separated. As such, when apatient applies the specimens to the two sample wells 608 and the testresults are exhibited, there is a high probability that two tests wereperformed at the same time associated with the same patient.Additionally, and electronic chip (not shown) can be embedded within thehousing 602 such that the housing 602 can be registered to a specificpatient and associated with the medical records of that patient.

Referring now to FIG. 7, there is illustrated a flowchart of oneembodiment of a testing device use method 700. The method 700 begins atstep 702 where a biologic is collected in a sample well or wells of atesting device. The biologic collected may be a non-diluted ornon-manipulated biologic, such as blood, urine, or saliva from the userof the test. Diluted or manipulated biologics may be used instead, asrequired by the specific test. For example, if a viral test requires thebiologic to be added to a solution, the biologic could be added to asolution that has previously been placed in a sterilized vial providedwith the testing device. After the required amount of time has passed,the solution containing the biologic could be deposited into the well orwells. At step 704, the biologic contacts a sample pad disposed on astrip or strips within the testing device. At step 706, the biologicmigrates along the strip or strips to come into contact with a conjugatepad containing antibodies. Antibodies present in the biologic willcomplex with the antibodies in the conjugate pad to create an immunecomplex. At step 708, the biologic migrates into a test zone of thestrip or strips, coming into contact with an antigen. The antibodies inthe conjugate pad serve to provide a means of detection, such as acolored response, if the immune complex binds with the antigen presentin the test zone of the strip. At decision block 710, binding of theantibodies with the antigen may or may not occur depending on ifantibodies associated with the antigen are present in the biologic ornot. If a binding between the antibodies and the antigen does not occurthe process moves to step 712 where no qualitative response is producedon the test line. If a binding does occur, at step 714 a qualitativeresponse is produced on the test line. Whether a binding occurs or not,and whether a qualitative response is produced or not, the process movesto step 716 where the biologic migrates into a control zone of the stripor strips where excess conjugates get bound and produces a qualitativecontrol zone reaction indicating that the sample has adequately migratedacross the testing zone.

It will be understood by one skilled in the art that the antibodies andantigens applied to the testing strip may be altered depending on thetype of condition being tested. For example, in the case of testing formedical conditions that do not involve an illness or infection, likepregnancy, and thus the sample biologic does not contain antibodiesassociated with the condition, antibodies that react to markers beingtested for may be applied to the testing strip instead of an antigen.For instance, pregnancy test requires testing for the presence of hCG.Since hCG is a hormone and not an antibody produced in response to aninfection, the testing strip may have antibodies that will react to thepresence of hCG applied to the testing zone or line of the testingstrip, as well as to the conjugate pad. Similarly, some tests mightrequire antibodies be applied to the testing strip to detect antigenspresent in the sample, rather than antibodies.

Referring now to FIGS. 8A and 8B, there is illustrated a diagrammaticview of one embodiment of a process 800 for a mobile device applicationfor testing device image capture and image processing. The mobile deviceapplication allows for an image of a testing device, such as testingdevice 300, to be captured using a camera installed on a mobile device802 having a screen 804. While the mobile device 802 displays on thescreen 804 the scene captured by the camera, the mobile deviceapplication also displays a graphic on the screen 804 in the form of aboxed outline 806, the size of the outline 806 corresponding to the sizeof the testing device 300. Also displayed on the screen of the mobiledevice 802 within or near the outline is a crosshair graphic 808. A userof the mobile device 802 attempts to align the outline 806 with theborders of the testing device 300 and also attempts to align thecrosshair graphic 808 with the crosshair 310 on the testing device 300.While alignment has not yet been achieved, a misalignment warning 810may appear on the screen of the mobile device 802, indicating to theuser that alignment has not yet been achieved. Such is shown in FIG. 8A.

In FIG. 8B, there is shown the result of a successful alignment of theoutline 806 with the testing device 300 and successful alignment of thecrosshair graphic 808 with the crosshair 310 on the testing device 300.As shown in FIG. 8B, once aligned, a success indicator 812 may appear,such as a check mark or other positive status symbol, on the alignedimage. Successful alignment causes the camera on the mobile device 802to capture the current image of the testing device 300. Other checks mayoccur, including ensuring that the image is focused before the image issaved. This image is then processed to determine a result based on theseverity of the reaction occurring on the test strip. The mobile deviceapplication performs an analysis of the test line captured in the image,counting the number of colored pixels, as well as determining theintensity of the color. The mobile device may then compare this numberand color intensity to that in the control line, providing amathematical evaluation of the test line. Utilizing unique wavelengthsof light for illumination in conjunction with either CMOS or CCDdetection technology, a signal rich image is produced of the test linesto detect the colloid gold or latex particles. This provides anadvantage because a user simply looking at the two lines may not knowwhat the test line indicates, such as when the colored line does appearson the strip, but it is a faded line, rather than a dark line. Based onthis analysis, the mobile device application may provide a resultsindicator 814.

The results indicator 814 may be a qualitative result or a quantitativeresult. For example, and as shown in FIG. 8B, a qualitative result forthe results indicator 814 may indicate, in the case of a testing devicefor testing pregnancy as well as an infection, a plus sign next to aline reading “pregnant:” and a plus sign next to a line reading“infection:” to indicate that the user is both pregnant and infectedwith the bacteria or virus being tested, such as the Zika virus. For aquantitative result, the results might provide a numeric rating. Forinstance, a rating system between 1-100 may be used. If the resultsprovide a low rating to the user, such as a rating of 10, this indicatesa low risk of infection, although medical attention may be sought by theuser anyway. For example, if the user is pregnant, and also receives a10 rating for Zika, this may indicate that Zika was detected in lowamounts. However, the user may still seek medical attention or furthertesting from her doctor because Zika has been known to cause birthdefects. If the rating is a high rating, such as 95, this indicates thatan infection has most likely occurred and medical attention should besought immediately.

This same quantitative rating system may be applied to any test (viralinfections, bacterial infections, pregnancy, and other healthconditions), as the quantitative test can be performed using thesoftware described herein to accurately test bound antibodyconcentrations on the test strip. In some embodiments, a combinedqualitative and quantitative result may be presented, such as both arating and a plus or minus sign being presented, or other types ofquantitative and qualitative indications. Additionally, variouscombinations of tests may be provided for in the testing device, such aspregnancy/Zika, preganancy/flu, pregnancy/strep/Zika, etc.

Referring now to FIG. 9, there is illustrated a flowchart of oneembodiment of an image analysis process 900 using a mobile device. Atstep 902 a mobile device application is launched. At step 904 a cameraon the mobile device is activated and a crosshair indicator and atesting device outline appear on the mobile device screen. At step 906the crosshair indicator presented on the screen of the mobile device isaligned with a crosshair icon on the testing device and the deviceoutline presented on the screen of the mobile device is aligned with theborders of a testing device. At step 908, an indicator of successfulalignment is presented on the screen and an image of the testing deviceis taken by the mobile device camera. At step 910, the mobile deviceapplication processes the image of the testing device to determine testline strength by counting the number of colored pixels contained in thetest line. At step 912, the mobile device application correlates lineintensity with analyte concentrations to further determine test linestrength. At step 914, the mobile device application presents the testresults based on pixel count and line intensity, providing either aqualitative or quantitative result.

In some embodiments, the number of pixels indicating bound antibodies onthe strip may be measured against that in the control line to compareline intensity between the two lines, with the control line acting as anexample of a strong reaction, indicating a strong infection, anddetermining how close the test line intensity is to the control line.This would lead to a logical quantitative result. For instance, if thetest line is determined to have a pixel count and line intensity that is25% of the pixel count and line intensity of the control line, a ratingof 25 may be given. If a qualitative result is to be provided, a ratingof 25 may give a qualitative result that is negative, or it could bepositive depending on the type of condition being tested and knownactual infection results where a rating of 25 occurred for thatcondition.

In some embodiments, the test line may not be compared with the controlline to determine a result. Rather, the mobile device application mayhave access to a database having data on numerous past tests for thesame condition. This data may instead be used as the control. Thisallows the application on the mobile device to retrieve data on pasttests and compare the test line data of the current test to past tests.Overall data for past tests may be provided and compared against, suchas providing an average or a curve of past tests, or individual testsrated as having accurate results may be compared against.

In addition to a status result of an infection or other medicalcondition being provided to the user, other indicators of health mayalso be tested and results thereon provided. This provides for potentialearly identification of pregnancy and risk of morbidity, allowing formedical attention to be sought much more quickly. Indicators of healthmay be detected from biologics, such as urine and blood. Urine, forexample, allows for the detection of glucose levels, proteins, bacteria,and infectious markers. In the case of glucose, glucose is usually notfound in urine, but, if it is, that is an indicator of extremely highlevels of glucose in the body, where the kidneys release excess glucoseinto urine. This is often a sign of diabetes. Protein in the urine mayindicate a malfunctioning of the kidneys, which could be the result ofhigh blood pressure. Similarly, if blood is detected in urine, it couldbe a sign of a problem with the kidneys or the bladder. Blood, forexample, allows for the detection of glucose, inflammation, hormones,genetic defect risks, and metabolic endocrine disorders.

Referring now to FIG. 10, there is illustrated another embodiment of asuccessful alignment of the outline 806 with the testing device 300 andsuccessful alignment of the crosshair graphic 808 with the crosshair 310on the testing device 300, wherein quantitative results for health riskindicators are provided. In this embodiment, the results indicator 814provides a qualitative result for pregnancy, and quantitative resultsfor other health risk indicators. In the embodiment shown in FIG. 10,the health risk indicators being tested are markers for blood pressureand for glucose levels. For blood pressure, this is a test for markersin the blood that can be associated with high blood pressure. Thesecould be test for such things as low levels of vitamin D and the such.Studies have shown that patients suffering from essential hypertensionwill be under oxidative stress and Malondialdehyde (MDA) is theprincipal and most studied product of polyunsaturated fatty acidpre-oxidation. This can show an indirect correlation with anti-oxidants,particularly with superoxide dismutases (SODs) (r=0.573) and catalase(r=0.633) representative anti-oxidant are involved in reducing thestress of a patient's biological system during hypertension. Anothermarker for hypertension is buildup of uric acid, where in uric acid is amarker for xanthine oxidase-associated oxidants and that the lattercould be driving the hypertensive response. Additional markers arecortisol, a hormone. The test strips 604 can test for the differentbiological markers.

The results indicator 814 provides numeric ratings, in this case, 1-100,with the blood pressure rating being 88 and the glucose rating being 95.This indicates that both blood pressure and glucose are extremely high.Due to this, an additional alert indicator 1002 is presented to the useron the screen of the mobile device, alerting the user to seek medicalattention immediately. This is to ensure that the health of both thepregnant woman and the fetus can be checked as close to the time ofpregnancy detection as possible and medical attention received ifneeded.

Referring now to FIG. 11, there is provided a flowchart of oneembodiment of a pregnancy disease risk assessment process 1100. Theprocess 1100 begins at step 1102 where a biologic is collected anddeposited in a testing device for testing of the biologic. At step 1104,the biologic is processed by the testing device for detection ofpregnancy and various other medical conditions. These medical conditionsmay be high blood pressure, diabetes, bacterial or viral infections,inflammation, an increase in hormone levels, genetic disease markers,and/or metabolic disorders. At step 1106, a mobile device is used tocapture an image of the testing device after testing is complete. Insome embodiments, test results may be immediate. In other embodiments,and depending on the medical conditions being tested, the test may takea certain amount of time to complete. In this case, the user of the testwould be alerted to this fact in instructions provided with the testingdevice. Additionally, a visual indicator on the testing device may alertthe user that a test is now complete. At step 1108, the mobile deviceprovides a rating for each medical condition being tested, such as thatdescribed with respect to FIG. 10 herein.

At decision block 1110, it is determined whether the ratings for eachcondition exceed a certain threshold for that condition. If not, theprocess 1100 moves to step 1112, where an indication is presented to theuser via the mobile device screen that medical attention is notcurrently advised or necessary. If at decision block 1110 it isdetermined that at least one of the medical conditions being testedrises above a certain threshold, the process 1100 moves to step 1114where a warning is presented to the user via the mobile device screenthat medical attention is advised. The thresholds for medical conditionsmay not trigger a warning even if a rating exceeds a threshold, if, inthe event of multiple tests being performed, the combined test resultsdo not warrant immediate medical attention. For example, if a user istesting for a cold virus, blood pressure, and glucose, and only the coldvirus rating is above the threshold, there may not be a warning providedto the user. Additionally, ratings may be weighted or aggregated basedon the medical conditions being tested. For example, if blood pressure,inflammation, and glucose are being tested for, and they all are givenonly moderate ratings that do not rise above the threshold for anycondition individually, an warning to seek medical attention may stillbe provided due to the combination of conditions taken together.

Referring now to FIG. 12, there is illustrated one embodiment of aconsumer driven biologic and disease data collection system 1200. Datacollected from users performing the tests disclosed herein effectivelycan provide a wealth of information. As tests are performed data may bepassed by a plurality of mobile devices 1202 being used by usersperforming tests to a database 1204, the database being at a remoteserver 1206, over a network 1208. The user is sourcing a biologic fromuser's own body. This is done at home, not in a lab, hospital, orclinic. Each particular test would expect a certain type of biologic tobe provided. For instance, for a pregnancy test, a urine sample isprovided and tested for pregnancy markers. For a stool test, the stoolmight be dissolved in a vial with a solution provided with the testingdevice/kit, and tested for various disease or infectious markers. Dataand results from the tests may be stored on the database 1204 at theremote server 1206. As described herein, this data may be used as acontrol for testing analysis for users of the plurality of mobiledevices 1202. This data may also be used to provide data sets forbiologics to a medical organization 1210. The medical organization 1210may be doctor's offices, researchers, hospitals, testing labs, and otherindividuals or organizations that have an interest in the health andanalysis of users taking the test and of their biologic samples. In thisway, data can be gathered from a variety of biologics tested for avariety of different medical conditions and characteristics.

Referring now to FIG. 13, there is illustrated an example of a uniquebiologic ID database table 1300. The table 1300 is illustrative of thetype of data stored in association with data for a biologic transmittedby the plurality of mobile devices 1202 for storage on the database1204. A biologic ID header 1302 is provided that shows that the biologicsample has been given a unique ID. All data concerning the biologic maybe stored in association with the unique biologic ID. The table 1300also includes a biologic type entry 1304. This designates what type ofbiologic that the biologic associated with the unique ID is, such asblood, urine, stool, saliva, sweat, or other biologics. The table 1300also provides a plurality of test ratings 1306, for various testsperformed on the biologic. In the example shown in FIG. 13, a bloodbiologic is provided having an assigned ID of 2402, and having beentesting for pregnancy markers, the Zika virus, and for glucose levels.The rating for pregnancy was a 99 rating, the rating for a Zikainfection was a 75, and the rating for glucose levels was a 10. Thiswould indicate that the test subject has an extremely high likelihood ofboth a pregnancy and a Zika infection, which would have resulted in awarning to seek medical attention at the conclusion of the tests. Otherinformation may also be stored in the database in relation to thebiologic, including other condition ratings, time and date each test wasperformed, user information such as ethnicity, gender, and age, andstatus indicators such as whether a test subject visited a physician asa result of the tests. The database 1204 thus provides the test subjectwith a growing collection of information that may be accessed by thetest subject. This allows the test subject to present the test resultsto her physician for medical attention or additional testing, and allowsfor others who may access the database, such as disease researchers, tohave access to data on various biologic samples and their markers.

Referring now to FIG. 14, there is illustrated a flowchart of oneembodiment of a biologic data collection and dissemination process 1400.The process 1400 begins at step 1402 where a user of a testing devicecollects a biologic sample for use in a test or a series of tests. Atstep 1404, the test or series of tests are performed on the biologicsample. At step 1406, a mobile device application checks the biologicsample the testing device result to determine a quantitative result ofthe test to provide a correlative value for the condition being testedin the biologic sample. At step 1408, the test results and correlativevalues, or multiple values if multiple tests on the biologic sample wereconducted, are transmitted to the remote server 1206. At step 1410, thebiologic sample is given a unique identification number in the database1204. At step 1412, the test results and correlative value or values arestored in the database 1204 in association with the uniqueidentification number given to the biologic sample collected and inassociation with the particular tests performed. This way, theparticular biologic sample may have various characteristics stored andretrieved in association with the biologic sample, and the test resultsmay also be retrieved when data on a particular test is needed on across-section of users.

At step 1414, the results are provided to the user on the user's mobiledevice. At step 1416, the results are provided to the user's healthcareprovider. The healthcare provider may receive the test results due to avisit from the user, the user bringing the results of the test with heron her mobile device, or the healthcare provider may receive the resultsfrom the database 1204 if the healthcare provider has permission toaccess the database 1204, or if access is granted in anticipation of theuser's appointment with the healthcare provider. At step 1418, the testresults are also provided to other healthcare industry individuals andorganizations, including medical researchers, hospitals, and others.

Referring now to FIG. 15, there is illustrated a perspective view of asystem for scanning test strips. The housing 602, as describedhereinabove with respect to FIG. 6, is illustrated as being disposedwithin a slot 1502 in a test housing 1504. The test housing 1504 isconnected through a line 1506 to a PC 1508. When the housing 602containing the test strips 604 after being subjected to the biologics isinserted within the slot 1502, the test housing 1504 will scan the teststrips 604 and analyze the results with the PC 1508. The PC 1508 willrun some type of algorithm that can analyze the results of both of thetest strips 604. There can be provided to indicators 1510 and 1512 onthe surface of the test housing 1504, one being, for example, a readyLED and one being a green LED. The PC 1508, after analyzing results, canthen provide a warning indicator such as lighting up the green LED for apositive indication of pregnancy and the red LED for indicating thatthere is some issue. As an example, suppose that the second test striptested for the Zika virus. If so, a warning would be appropriate tooutput and activate the red LED. There could be any other type ofindicator associated with the second test at 604 that, in a combinationwith the test results of the first test strip, i.e. for testing for thepresence of a pregnancy state, testing for such things as diabetes, etc.Further, although only two test strips 604 are illustrated, there couldbe multiple test strips testing for many different biological issuesthat may be present in an individual. In this embodiment, by insertingthe housing 602 into the test housing 1504 and allowing the PC 1508 toanalyze the results, the indicators associated with the test strips canbe analyzed with the assumption that all of the test return results wereassociated with an individual and in proximate time to each other. Thatmeans that the individual patient applied biological specimens, such asurine, blood, etc., to the appropriate test strips and, since these wereall contained within the same test strip housing 602, this provides anindication that they are associated with a single patient. Further, thetest performed will typically be a test that will provide a veryshort-term response. Thus, the specimens can be applied to the teststrips 604 in the test strip housing 602 and then inserted within theslot 1502 for testing by the PC 1508.

Referring now to FIG. 16, there is illustrated a cross-section of thetest housing 1504. It can be seen that the test strip housing 1504 ispassed in slot 1502 past the camera 1602. The camera 1602 is operable toscan a small cross-section of the test strips 604 on the surface thereofas the test strip housing 602 passes thereby. Of course, there couldalso be a much larger camera provided for taking an entire image of thetest strips 604 after being inserted within the test housing 1504. Thecamera 1602 is connected via a wire 1604 two in electronics package 1606to process the information and send it to the PC 1508. The electronicspackage 1606 will also drive the indicators 1510 and 1512.

Referring now to FIG. 17, there is illustrated one embodiment of avertical flow immunoassay device 1700. It will be understood thattesting device 300 and other embodiments herein illustrate a lateralflow immunoassay device. However, other types of immunoassay devices maybe used. For example, vertical flow immunoassay devices may be used, atwo-sided flow through assay, or even a sandwich ELISA test may be run.

The testing device 1700 includes a housing 1702 that forms the body ofthe testing device. The housing 1702 may be made of plastic, metal, orany material durable enough for shipping and subsequent handling by auser. The housing 1702 may be hollow so that a plurality of immunoassaytest pads 1704 may be housed within and so that a biologic may bedeposited within the housing 1702. The testing device 1700 may furtherhave a plurality of sample wells 1706, each sample well having one ofthe plurality of immunoassay test pads 1704 disposed within, andallowing for a user to view at least a section of a nitrocellulosemembrane of each of the immunoassay test pads 1704, the membrane havinga test line 1708 and control line 1710. The testing device 1700 may alsohave disposed on the surface of the housing a crosshair symbol 1712,used as an alignment target. This symbol may be a graphic printed oradhered to the testing device 1700. The crosshair symbol 1712 is used toalign the testing device 1700 for the taking of an image of the testingdevice 1700 using a camera on a mobile device, for use in a mobiledevice application described herein. In other embodiments, the crosshairsymbol 1712 may be other types of symbols, such as a simple shape(circle, square, etc.), other images (such as a medical cross symbol, anarrow, etc.), or any other type of image. In other embodiments, thedevice 1700 may be configured in such a way as to allow a biologicsample to be deposited into a sample well, and to present the results ofthe test on the opposite side of the housing. Such a configuration wouldallow the biologic to flow through the testing pad within the housing,with the reaction occurring on a reactive membrane on the side of thedevice opposite the sample well, with the device having a window forviewing the results.

Referring now to FIG. 18, there is illustrated a cross-sectional view ofone embodiment of the vertical immunoassay device 1700. There is shownone of the plurality of immunoassay test pads 1704 residing within thehousing 1702 below one of the plurality of sample wells 1706. The one ofthe plurality of immunoassay test pads 1704 includes a immunoreactivemembrane 1802, such as the nitrocellulose membranes disclosed herein.The immunoreactive membrane 1802 may have particle conjugates disposedthereon that binds when a biologic sample is received onto theimmunoreactive membrane 1802 via the sample well 1706, if the biologicsample contains the antigens or antibodies, or other indicators, forwhich the test is configured. The one of the plurality of immunoassaytest pads 1704 also includes an absorbent pad 1804 for collection ofexcess biologic sample. It will be understood that the cross-sectionalview illustrated in FIG. 18 shows one well of the plurality of samplewells 1706. The other wells included in the device 1700 would beconfigured in a similar manner as that shown in FIG. 18. There may alsobe included in the device 1700 an inner separating wall between each ofthe plurality of immunoassay test pads 1704, to ensure that excessbiologic material that is not adequately absorbed by the absorbent pad1804 does not contaminate neighboring immunoassay test pads.

Referring now to FIG. 19, there is illustrated a color gradient chart1900. When the mobile application described herein captures an image ofthe testing device, in some embodiments each pixel that makes up thetest line captured in the image is processed to place it on a colorgradient scale. In some embodiments, this placement may be done byexamining the RGB values of the pixel. For any given test, there may bea visual color indicator (such as a test line) presented to the user ofthe test to indicate whether a reaction occurred. The color that is tobe presented is known for the given test. Additionally, in someembodiments, the strength of the reaction will affect the strength ofthe color indicator. For example, if a test is supposed to produce abrown colored indicator, an image can be taken of the colored indicatorto examine each pixel of the colored indicator to determine the strengthof the color produced on the testing device, which indicates thestrength of the reaction, and thus the risk level for the user.

The embodiment illustrated in FIG. 19 uses as an example a set of pixelRGB results for a test that produces a red colored indicator on the teststrip when a reaction has occurred. There can be seen an origin point1902 on the chart 1900, wherein the RGB value is (255, 255, 255) orwhite. This may represent a no reaction state for the test strip, sincethe test line on the strip may only appear as a white blank space if noreaction has occurred. An x axis 1904 represents the color green,wherein the amount of green in the pixel decreases as it moves away fromthe origin in relation to the x axis 1904. A y axis 1906 represents thecolor blue, wherein the amount of blue in the pixel decreases as itmoves away from the origin in relation to the y axis 1906. A diagonalline 1908 running in between the x axis 1904 and the y axis 1906represents the color red, wherein the diagonal line 1908 running throughthe center of the chart 1900 is a maximum red color all along thediagonal line 1908. If a pixel has less red than a 255 value, the pixelwould be plotted away from the diagonal line 1908 in relation towhichever color is more predominant. For instance, if the pixel has RGBvalues of (127, 50, 205), a shade of purple, the pixel would be plottedsomewhere in the lower right quadrant of the chart 1900. FIG. 19 furtherillustrates an example plurality of pixel plot points 1910, connected bya curved line, wherein the example plurality of pixel plot points 1910shows tests results that likely indicate a positive reaction, as theplot points are all located near the diagonal line 1908, demonstratingthat the colored indicator was a heavy red color for the most part.

Referring now to FIG. 20, there is illustrated a normalized past testsresults chart 2000. The captured pixels may be normalized into a singlevalue for determining whether there is a likelihood of infection,pregnancy, or whatever else the test is designed to detect. This may bedone in various ways. For example, the shade of red in all the pixelsmay be averaged to reach a single RGB value. Outliers may be left out sothat the average is not heavily skewed, especially when there are fewoutliers present. This RGB value may then be given a value, such as arisk rating, ranging from 0 to 100. For example, an RGB value of (255,255, 255) would be given a rating of 0. An RGB value of (255, 0, 0)would be given a rating of 100. An RGB value of (205, 150, 75) may begiven a rating of 70, and so on. This normalized value may then be usedto compare the user of the test to users of past tests to determine arisk level. In some embodiments, the control line and the test line maybe captured and the results compared, as well. In addition, the realresults of risk levels may also be used to adjust the stored normalizedvalue. For instance, if a particular RGB value that seems to indicate astrong reaction repeatedly was found to not indicate an infection, thisvalue may be adjusted to provide a lower risk rating. For instance, if aphysician who saw a patient who had a (205, 150, 75) RGB value laterreported to the operator of the server 1206 that further testing showedno infection was present, and if this trend continued substantially asreported by other physicians or medical organizations, subsequent testresults by other test users that were near the RGB value of (205, 150,75) may be given a lower rating.

Chart 2000 illustrates how past tests results may be collected and usedto determine the risk of a current test user. A y axis 2002 represents arisk level rating, ranging from 0 at the origin to 100. An x axis 2004represents time, wherein a plurality of normalized test results isplotted on the chart 2000. The chart 2000 is further divided intosections across the y axis 2002, indicating various risk levelthresholds. For instance, and as illustrated in the chart 2000, theremay be at certain rating levels different thresholds of risk labeled aslow, moderate, above average, and high risk levels. These thresholds maybe moved over time as more data is accumulated via users conductingtests and the mobile application storing the data on the tests. When auser conducts a test, the user's normalized rating can be plottedsimilarly to past test results and weighed against them in order toprovide a risk level for the user.

Referring now to FIG. 21, there is illustrated the mobile device 802displaying on the screen 804 a mobile application variable testfunctionality. There is displayed on the screen 804 a plurality of testfunctions 2102. The plurality of test functions 2102 may be buttons thatcan be selected by a user to switch between tests within the mobileapplication. This allows for all test functions to be within the samemobile application. For each test run by the mobile application, datafor the particular test chosen is utilized in performing the test,pulling the data from the remote server 1206.

Referring now to FIG. 22, there is illustrated the mobile device 802 ofFIG. 8B, wherein the housing 302 of the testing device 300 also includesthereon test function indicators 2202 and 2204. The test functionindicators 2202 and 2204 are visual markers located on the housing 302that identify to the mobile application the types of tests for which thetesting device 300 is configured. These indicators may be any symbol,alphanumeric character, shape, etc. that can be added to the surface ofthe testing device 300. The mobile application is programmed torecognize the indicator and perform the test function associated withthe indicator. For example, the embodiment illustrated in FIG. 22 showsa “P” symbol for test function indicator 2202 and a “Z” symbol for testfunction indicator 2204. In this embodiment, test function indicator2202 indicates that one test strip in the testing device 300 is apregnancy test, while test function indicator 2204 indicates that onetest strip in the testing device 300 is a Zika test. This is used formerely illustrative purposes, and any recognizable symbol may be usedfor these two test functions, and any other type of test may have asymbol assigned in this way as well. Further, in some embodiments theremay only be one indicator on the housing 302, even if there are multipletests. This single indicator would be for the combined test. Forexample, if the testing device 300 of FIG. 22 had a single symbol of“PZ,” this would indicate that the testing device 300 is a combinedpregnancy and Zika testing device, allowing for the mobile applicationto recognize such and perform each test with knowledge of which strip isassociated with which test based on the stored data on the testingdevice associated with the “PZ” symbol.

Referring now to FIG. 23, there is illustrated a medical codecorrelation system 2300. The system 2300 includes a mobile device 2302,which is configured to run the mobile application described herein. Themobile device 2302 is connected to a database 2304 disposed on a server2306, over a network 2308. To correlate a medical code, the mobiledevice first passes a diagnostic test identifier to the remote server.This identifier allows for the type of test being used by the user ofthe mobile device 2302 to be determined. The identifier may simply bethe name of the test, may be a number associated with the test, or anyother means of identifying the test being performed by the user of themobile device 2302. This may be done when the phone capture the image ofthe testing device to process the results, or the user may enter thetest to be performed before a test is conducted, at which time themobile device 2302 may pass the identifier to the remote server. Inother embodiments, the diagnostic test identifier may even be themedical code. For example, if the diagnostic test is a strep test, theidentifier may be G0435, an HCPCS code for a rapid immunoassay test, orany other appropriate medical code.

Once the physical test results of the diagnostic test is captured, andonce the results are processed by the mobile device 2302 or the server2306, the results are also received by the server. Once the server 2306has the diagnostic test identification and the results of the test, theserver 2306 may then correlate the specific test and the results withappropriate medical codes stored within the database 2304. It will beunderstood that the database 2304 may be physically located with theserver 2306, or the database 2304 may be a remote database, such as acentralized database that allows entities within the healthcare industryto retrieve the latest medical codes. The medical codes assigned maythen be transferred from the mobile device 2302 to a healthcare entity2310. In other embodiments, the medical codes may be transferred fromthe server 2306 to the healthcare entity 2310. The healthcare entity2310 may be a physician, a hospital, a pharmacy, an insurance company,or any other entity that may provide the user with further assistance.

Referring now to FIG. 24, there is illustrated a strep home retail testcodes table 2400. The table 2400 lists the various medical codes thatmay be associated with a home testing device that is used to test for astreptococcal infection. The table 2400 is representative of the typesof codes that may be stored in the database 2304 in relation to aparticular retail strep test device. The table 2400 lists a diagnosiscode of J02.0, an ICD-10-CM code for streptococcal pharyngitis. Thetable 2400 also lists an HCPCS code of G0435, which is a code for arapid antibody test. The table 2400 also lists an NDC code of54569-5182-0, which is the NDC code for an amoxicillin prescription.Thus, when the server 2306 assigns the medical codes to the testingdevice or the test results, various codes may be produced. The exampleshown in table 2400 shows that the strep home retail testing device isassigned the HCPCS code of G0435 to indicate the type of test it is, arapid antibody test. If the test results come back as positive, theserver assigns the ICD-10-CM code to this event, indicating astreptococcal throat infection. In response to these positive testresults, the server 2306 provides the NDC code for amoxicillin as arecommended prescription to give to the user to treat the infection.

In some embodiments, this prescription may be passed to a pharmacy sothat the pharmacy may fill the prescription for the user to pick up, orto be delivered to the user. In some embodiments, the medical codes andother information may be passed to a physician for review. Thisphysician may be the primary care physician of the user, allowing theuser to set an appointment to go over the test results and get aprescription from the physician. In other embodiments, the physician maybe a telemedicine physician that either the user contacts, the physiciansets up a telemedicine conference, or the system described hereinautomatically initiates in response to the test results. The physicianmay alter the recommended prescription provided by the system, mayconduct additional testing, or otherwise handle the situation as he orshe sees fit as a physician. In addition, in some embodiments, themedical codes may be passed to an insurance company to seekreimbursement for the testing device, the prescription, the visit withthe physician, or any other costs that arise from this testing event. Toaccomplish such, the user may have provided his or her insuranceinformation when signing up to use the mobile application in conjunctionwith the various testing devices provided.

Referring now to FIG. 25, there is illustrated a combined pregnancy andZika home retail test codes table 2500. The table 2500 lists the variousmedical codes that may be associated with a home testing device that isused to test for both pregnancy and a Zika infection. The table 2500 isrepresentative of the types of codes that may be stored in the database2304 in relation to a particular retail pregnancy/Zika testing device.The table 2500 has a pregnancy codes column and a Zika codes column. Thepregnancy codes column lists a diagnosis code of Z33.1, an ICD-10-CMcode for a pregnant state. The pregnancy codes column also lists anHCPCS code of G8802, which is a code for a pregnancy test. The pregnancycodes column also lists an NDC code of 42192-321-30, which is the NDCcode for prenatal vitamins. The Zika codes column lists a diagnosis codeof A92.5, an ICD-10-CM code for the Zika virus. The Zika codes columnalso lists an HCPCS code of G0435, which is a code for a rapid antibodytest. The Zika codes column also lists an NDC code of 50580-501-30,which is the NDC code for prescription strength Tylenol. In someembodiments, instead of separate codes for each type of test performed,there may be a single code assigned to, for example, a combinedpregnancy and Zika test, or even a single code for a pregnant with Zikainfection state.

It will be understood that the codes listed in FIGS. 24-25 are examplesof how the system may assign codes to a testing event. The use of thespecific codes and the types of codes (ICD-10-CM, HCPCS, and NDC codes)are merely used for illustrative purposes; any type of codes may be usedand the specific codes listed in FIGS. 24-25 may be other, moreappropriate, codes for the particular testing device, diagnosis, etc.Different types of codes include, but are not limited to, ICD-9-CM,ICPC-2, NANDA, Read code, SNOMED, CCI, CDT, NIC, NMDS, NOC, CCAM,OPCS-4, or other codes.

Referring now to FIG. 26, there is illustrated a flowchart of oneembodiment of a medical code correlation process 2600. The processbegins at step 2602 where the mobile device 2302 running the applicationdescribed herein transmits a diagnostic test identifier to the remoteserver 2306. At step 2604, the remote server 2306 correlates thediagnostic test identifier with a medical code associated with theparticular diagnostic test. This identifier allows for the type of testbeing used by the user of the mobile device 2302 to be determined. Theidentifier may simply be the name of the test, may be a numberassociated with the test, or any other means of identifying the testbeing performed by the user of the mobile device 2302. This may be donewhen the phone capture the image of the testing device to process theresults, or the user may enter the test to be performed before a test isconducted, at which time the mobile device 2302 may pass the identifierto the remote server. In other embodiments, the diagnostic testidentifier may even be the medical code. For example, if the diagnostictest is a strep test, the identifier may be G0435, an HCPCS code for arapid immunoassay test, or any other appropriate medical code.

The process then flows to step 2606, where the mobile device 2302, aspart of the overall operation of the system and mobile applicationdescribed herein, capture an image of the testing device for processing.At step 2608, the image is processed to achieve the test results. Suchprocessing may be performed on the mobile device 2302, on the remoteserver 2306, another server, or any other device that may be interfacedwith the system disclosed herein. The process then flows to decisionblock 2610, where it is determined whether the test results indicated apositive result (positive infection, pregnancy, or other outcomes). Ifthe test result is positive, the process flows to step 2612, where theremote server 2306 correlates a medical code with the test results. Asdescribed herein, components other than the remote server 2306 maycorrelate the test results with a medical code, such as a centralizedserver and database used in the healthcare industry to retrieve medicalcodes. The process then flows to step 2614 to assign a recommendedpharmaceutical product based on the test results. This may be an NDCcode for a product, and there may even be provided a prescription forsuch. At step 2616, the codes are transmitted to the appropriatehealthcare entities, such as a physician, a pharmacy, or other entities.

If at decision block 2610 it is determined that the test results arenegative, the process instead flows to step 2618, where no medical codeis correlated with the test results. This provides that no diagnosiscode if provided, since the test results indicate that the user is notpositive for the condition being tested. However, a medical code for thetest itself, determined at step 2604, may still be applicable in thisscenario, because the user still used the diagnostic test, and thereforemay still be reimbursed for the cost of the test, if the user'sinsurance company chooses to do so. The user's physician may also wantto see the test results, even if they are negative, and the code for thetest and the negative results may still be transmitted to the physician.Therefore, after step 2618, the process then flows to step 2616 totransmit the codes (in this case, the code for the testing deviceproduct) to the appropriate healthcare entities. The test resultsthemselves may also be transmitted.

Referring now to FIG. 27, there is illustrated one embodiment of atelemedicine initiation option within a mobile application. The mobileapplication and system described herein is predominantly meant to firsttest a patient for a medical condition, and then recommend an action,such as seeing a physician. However, the system allows for telemedicineconferences to be initiated, and therefore functionality may existwherein a user can request a telemedicine conference with a physician atany time while using the mobile application, in order to receive adiagnosis or simply to ask questions. Thus, FIG. 27 again shows theplurality of test functions 2102 displayed on the screen 804. Inaddition to these options, an additional option is presented to theuser. This option is a telemedicine conference button 2702 that allows auser to initiate a telemedicine conference with a qualified telemedicineprovider. This button 2702 is shown on the screen where the user selectsthe type of test to be performed, but the button 2702 may be presentedwithin the user interface on any screen of the mobile application.

Referring now to FIG. 28, there is illustrated another embodiment of atelemedicine initiation option within a mobile application. There isshown on the screen 804 the test results as previously shown on FIG. 22,which indicate positive pregnancy and Zika test results. In such asituation where the test results indicate a possible serious medicalcondition, a button 2802 may appear to the user on the screen 804. Thebutton 2802 may have a warning message within, urging the user to seek aconsultation with a physician to talk about the user's options in lightof the positive test results, and inviting the user to tap the button2802 to initiate a telemedicine conference with a physician. Tapping thebutton 2802 will initiate such a telemedicine conference. The physicianthat is connected with for the conference may be an on-call physicianthat has agreed to make his or her services available through the systemdescribed herein, the telemedicine conference may use an existedtelemedicine conference platform and physician base, the user's primarycare physician may be a user of the system and mobile application,allowing for them to be used as the default telemedicine contact for theuser, or other methods of making physicians available for a conferencewith the users of the mobile application may be provided.

Referring now to FIG. 29, there is illustrated one embodiment of atelemedicine conference session on a mobile device. During atelemedicine conference that has been initiated as described herein, theuser is presented with a video conference window 2902 on the screen 804.The video conference window 2902 allows for user to see the physicianthat is providing the telemedicine services to the user. It will beunderstood that the physician may have a similar video window on thedevice being used by the physician that allows the physician to see theuser. This allows the physician to make some visual observations of theuser's condition. In addition to the video conference window 2902, theuser is presented with a plurality of actions 2904 on the screen 804.The plurality of action 2904 may be buttons that allow the user toprovide the physician with further information. For example, one buttonmay allow for the user to send a photograph to the physician, such as aphotograph of the user's symptoms, or of the user's test resultspresented on the testing device. One button may also provide an optionfor sending the user's medical file to the physician, so that thephysician can review the user's medical history or other importantinformation. This medical file may include all the informationaccumulated from all tests performed by the user under the systemdescribed herein, and may also include all other medical historyinformation. The user may have provided a copy of his or her medicalhistory, or such may have been retrieved from a central electronicmedical records system.

Other actions that may be provided in the plurality of actions 2904 maybe a button to send test results to the physician. This would allow theuser to send the test results of the latest test the user took beforeinitiating the telemedicine conference, or it may allow for the user tochoose the test. The plurality of actions 2904 may also include a buttonfor sending the user's insurance information to the physician. The usermay have provided this information within the mobile application and hadit stored to the server, or this information may have been pulled forthe user based on the user's identification information. This optionallows the user to give the physician insurance information so that thephysician can use the user's insurance for reimbursement of thetelemedicine services, and may even set up reimbursement to the user forcertain services or products, such as the testing device used for thetest.

Referring now to FIG. 30, there is illustrated a flowchart of oneembodiment of a medical file handoff process 3000. The process 3000starts at step 3002 where a user is provided with diagnostic testresults at the conclusion of a performance of a test. At decision block3004, it is determined whether the test results provide a positiveresult. If not, at step 3006 the results are stored on the server of thesystem described herein and the process ends at end block 3016. If theresults are positive, the process flows to step 3008 where the resultsare stored on the server. At step 3010, it is determined whether atelemedicine conference has been initiated. This initiation may havebeen selected as described with respect to FIGS. 27 and 28, may havebeen initiated automatically due to the results provided, or may havebeen initiated in some other way. If the telemedicine conference was notinitiated, the process ends at end block 3016. If the telemedicineconference was initiated, the process flows to step 3012 where the testresults are passed to the telemedicine provider participating in thetelemedicine conference. The process then flows to step 3014, whereother user information is passed to the telemedicine provider. Theprocess then ends at end block 3016.

The passing of the results to the telemedicine provider and otherinformation at steps 3012 and 3014 may be performed by the user's mobiledevice, wherein the mobile device sends the files to the telemedicineprovider. The passing may also be done by the server of the systemdescribed herein, wherein the results and other information waspreviously stored to the server and the server then passes the resultsand other information to the telemedicine provider as a result of theserver being notified of a telemedicine conference initiation. The otheruser information of step 3014 may be any information needed by thetelemedicine provider, such as past medical records and history of theuser, past test results, insurance information, or any otherinformation.

Referring now to FIG. 31, there is illustrated a flowchart of oneembodiment of a telemedicine conference initiation process 3100. Theprocess 3100 starts at step 3102 where a user is provided withdiagnostic test results at the conclusion of a performance of a test. Atdecision block 3104, it is determined whether the test results provide apositive result. If not, at step 3106 the results are stored on theserver of the system described herein and the process ends at end block3118. If the results are positive, the process flows to step 3108 wherethe results are stored on the server. At step 3110 a telemedicine buttonis presented to the user on the screen of the mobile device, similar tothat shown in FIG. 28. This button recommends to the user that the userinitiate a telemedicine conference, since the test results indicate apositive reaction. At step 3112, it is determined whether a telemedicineconference has been initiated. This initiation may have been selected asdescribed with respect to FIGS. 27 and 28, may have been initiatedautomatically due to the results provided, or may have been initiated insome other way. If the telemedicine conference was not initiated, theprocess ends at end block 3118. If the telemedicine conference wasinitiated, the process flows to step 3114 where the test results arepassed to the telemedicine provider participating in the telemedicineconference. The process then flows to step 3116, where other userinformation is passed to the telemedicine provider. The process thenends at end block 3118.

The passing of the results to the telemedicine provider and otherinformation at steps 3114 and 3116 may be performed by the user's mobiledevice, wherein the mobile device sends the files to the telemedicineprovider. The passing may also be done by the server of the systemdescribed herein, wherein the results and other information waspreviously stored to the server and the server then passes the resultsand other information to the telemedicine provider as a result of theserver being notified of a telemedicine conference initiation. The otheruser information of step 3116 may be any information needed by thetelemedicine provider, such as past medical records and history of theuser, past test results, insurance information, or any otherinformation.

In some environments ambient lighting in a space cannot be controlled,resulting in images taken by a mobile device of a test kit to havedifferent color temperatures. Additionally, the optical design ofcameras that introduce color shifts due to chromatic aberration andother light lens interactions may produce images different in color fromother cameras. A lighting sensor in a mobile device may alsoautomatically adjust acquisition parameters. The camera software of themobile device may also perform processing of the image that alters thecolors in the image to be more pleasing to a human observer. This causeseach image acquired via a mobile device to have a unique color balance.For example, green colors in one image may not match the green colors inanother image. To account for this, various methods may be used tocontrol the color balance.

One such method is to perform colorimetric analysis, comparison, andquantification. Colorimetric analysis is a method of determining theconcentration of a chemical element or chemical compound in a solutionwith the aid of a color reagent. It is applicable to both organiccompounds and inorganic compounds and may be used with or without anenzymatic stage. In physical and analytical chemistry, colorimetry is atechnique that is used to determine the concentration of coloredcompounds in solution. Colorimetry can be used to determine theconcentration of any colored substance. Methods of taking colorimetricmeasurements may be made by using a light which passes through a colorfilter. The light is then passed through a small box or cuvette with theactual chemical substance. The wavelength of the light received is thenmeasured to determine the concentration of the target in the substance.

To introduce colorimetric analysis to the testing devices disclosedherein, the lighting environment may be controlled using by introducingcontrolled light sources to direct light into the environment or on thesubject of the image. The light sources introduced may be of variousintensities, colors, etc., depending on the type of test beingperformed. For example, a standard white light may be applied to anenvironment to wash out colors in the image, or colored lights, such asa green light, may be introduced to emphasize certain colors or filterout other colors.

Referring now to FIG. 32, there is illustrated an attachable lightingapparatus 3200. The lighting apparatus 3200 includes a circular body3202 having an aperture 3204 in the center therethrough. The circularbody 3202 may be of a thickness to allow one or more lights 3206 to bedisposed within. The one or more lights 3206 may be a single circularlight that fits within the circular body 3202. If the one or more lights3206 include more than one light, the one or more lights 3206 mayinclude series of lights arranged in a circular pattern around thecircular body 3202. The one or more lights 3206 may be light emittingdiodes (LEDs) or other types of lighting elements. In some embodiments,the one or more lights 3206 may be a white light in order to provide abrighter environment and wash out other color hues from the environmentduring the taking of an image using a mobile device. In otherembodiments, the one or more lights 3206 may be of a particular color.For example, the one or more lights 3206 may be a red light.

If the color of the test line (and the control line) after a successfulreaction is red for a particular test strip, red light will bereflected, causing the test line to still appear red. However, if thetest line does not undergo a strong reaction, and, for example, the testline appears to be a shade of pink or magenta, rather than true red, thered light would still be reflected, while traces of blue color in thepink or magenta color on the test line would be filtered out. Toemphasize a contrast between a red test line and a pink or magenta testline, blue light could instead by cast upon the test strip when takingan image of the test strip. In the case of a strong red test line beingproduced as a result of the test, the blue light would be absorbed,causing the test line to appear black, which may be useful indetermining whether the red test line actually is a strong reaction ornot. For example, if it is a strong reaction, the resultant image shouldshow a completely or nearly solid black line. However, if the test lineinstead was a pink or magenta shade, some blue light may still bereflected, causing the resultant image to show test line having a bluehue. The control line also may be used in the analysis. Since thecontrol line should react strongly despite the result on the test line,in the above example of a red line with blue light, the control lineshould appear black, which may be contrasted against the test line whichmay not completely black.

Other colors may be used in this way to emphasize and more closelyevaluate the test line. For example, a color may be introduced that isnot a primary color, such as magenta. If the test line is again red,magenta light would cause red to be reflected back, while absorbing theblue in the light. If the test line is not a strong red, some of theblue in the magenta light may still be reflected back, indicating aweaker reaction.

The one or more lights 3206 may be covered by a protective barrier madeof plastic, glass, or other materials that allow light to pass throughthe protective barrier while protecting the one or more lights 3206 fromdamage. The lighting apparatus 3200 may further include a clip 3208 forattaching the lighting apparatus 3200 to another device, such as amobile device. The clip 3208 may have a hinged clamp portion that clampsonto a mobile device, may be applied with an adhesive, or may be fixedusing fixation devices such as pins or screws to a mobile device. Theaperture 3204 may have a diameter large enough to fit over a lens of acamera on a mobile device such that the lens is able to operate to takeimages while the lighting apparatus 3200 is attached to the mobiledevice, with the circular body 3202 surrounding the lens withoutcovering any portion of the lens.

Referring now to FIG. 33, there is illustrated a light spectrumapparatus 3300. The light spectrum apparatus 3300 includes a circularbody 3302 having an aperture 3304 in the center therethrough. Thecircular body 3302 may be of a thickness to allow a plurality of lights3306 to be disposed within. The plurality of lights 3306 include morethan one light, the plurality of lights 3206 may include series oflights arranged in a circular pattern around the circular body 3202. Theplurality of lights 3306 may be light emitting diodes (LEDs) or othertypes of lighting elements. The plurality of lights 3306 may be each bea specific color, to provide a variety of colors onto the subject. Theplurality of lights 3306 may be covered by a protective barrier made ofplastic, glass, or other materials that allow light to pass through theprotective barrier while protecting the plurality of lights 3306 fromdamage. The light spectrum apparatus 3300 may further include a clipsuch as that described with respect to the lighting apparatus 3200 andas further described herein, to clip the light spectrum apparatus 3300to another device, such as a mobile device. The aperture 3304 may have adiameter large enough to fit over a lens of a camera on a mobile devicesuch that the lens is able to operate to take images while the lightspectrum apparatus 3300 is attached to the mobile device, with thecircular body 3302 surrounding the lens without covering any portion ofthe lens.

The light spectrum apparatus 3300 may be used in a similar manner to thelighting apparatus 3200 to introduce colored light onto the test strip.The light spectrum apparatus 3300 however may introduce a variety ofcolors without switching the lighting device attached to the mobiledevice. The light spectrum apparatus 3300 may allow for choosing whichcolored lights of the plurality of lights 3306 to activate. For example,only a primary color may be chosen to be activated, such as red lights,blue lights, or green lights present on the light spectrum apparatus3300 may be activated, or different combinations may be activated. Forexample, a combination of red and blue lights may be activated tointroduce a magenta color spectrum into the environment. In otherembodiments, lights included in the plurality of lights 3306 may simplybe magenta or some other non-primary color, without needing to combinedifferent lights.

Referring now to FIG. 34, there is illustrated an attachable colorfilter apparatus 3400. The color filter apparatus 3400 may include aringed body 3402 made of a material such as plastic. The ringed body3402 has fixed within a colored filter 3404. The colored filter 3404 maybe a plastic film or piece of thin glass that is a specific color, inorder to absorb colors other than that specific color from light passingthrough the colored filter 3404. For example, if a magenta filter isused for the colored filter 3404, green light would be absorbed by thecolored filer 3404. This may be combined with different wavelengths oflight to analyze the results on a test strip.

In the same example of using a magenta filter, if white light isintroduced, only blue and red light would be allowed through the magentacolored filter 3404, filtering out any green light. This may be usefulin analyzing a test strip that provides red colored test and controlline results, as the color temperatures of the test line and controlline could then be compared, while filtering out other wavelengths oflight. In other embodiments, other colored filters 3404 may be used,such as a blue filter. In the example where the test and control linesproduce red results, a blue filter may allow for any red reflected fromthe test and control lines to be filtered out. This would produce ablack result for the control line that could be compared against thetest line results. If the test line results include some blue in theresults, the blue wavelengths would still pass through the filter,indicating that the reaction of the test line was not as strong as thecontrol line.

Traditional colorimetry techniques may be applied to the resultsobtained as described with respect to FIGS. 32-34. The resultant colorof the test line as received by the camera allows for the specificwavelength of the color of the test line to be recorded, and thencompared to previous wavelengths recorded in previous tests stored inthe system disclosed herein, or compared to the wavelength of thecontrol line. The chosen color may additionally have a known wavelength,with the captured wavelength of the light reflected from the test lineand/or control line being compared to the known wavelength of the lightor filter, to determine how much light was absorbed by the test line andcontrol line. The wavelengths of the test line or control line in someembodiments may be approximated from the RGB values of the pixelscaptured in the image since wavelengths colors are known, thus assigninga wavelength value to the captured colors. In other embodiments, themobile device may have colorimeter capabilities to detect the wavelengthbeing returned to the mobile device. The colorimeter capabilities may bebuilt into the mobile device, or a colorimeter peripheral may be addedto the mobile device.

Referring now to FIG. 35, there is illustrated a mobile device 3502 witha colorimetry device 3504 coupled thereto. The colorimetry device 3504is attached over a lens 3506 of the mobile device camera. Thecolorimetry device 3504 may be a lighting apparatus, such as lightingapparatus 3200 or the light spectrum apparatus 3300 described herein, ormay be a colored filter such as the colored filter 3400 describedherein. In the case of a light apparatus, there may be an aperture inthe lighting apparatus such that the lens 3506 sits within the aperture,allowing the lens 3506 to still light and the camera to take images. Inthe case of a colored filter, the filter would cover the lens 3506 sothat the effect of the colored filter is applied to light received bythe lens 3506. In some embodiments, the colorimetry device 3504 may befixed to the mobile device 3502 using an adhesive, a clip, or othermethods.

Referring now to FIG. 36, there is illustrated a mobile device 3602 witha colorimetry device 3604 coupled thereto. The colorimetry device 3604is attached over a lens 3606 of the mobile device camera. Thecolorimetry device 3604 may be a lighting apparatus, such as lightingapparatus 3200 or the light spectrum apparatus 3300 described herein, ormay be a colored filter such as the colored filter 3400 describedherein. In the case of a light apparatus, there may be an aperture inthe lighting apparatus such that the lens 3606 sits within the aperture,allowing the lens 3606 to still light and the camera to take images. Inthe case of a colored filter, the filter would cover the lens 3606 sothat the effect of the colored filter is applied to light received bythe lens 3506. The colorimetry device 3604 may be fixed to the mobiledevice 3602 via a clip 3608 fixed to the colorimetry device 3604 andextending over the top of the mobile device 3602 to clamp against theback of the mobile device 3602. In some embodiments, the clip 3608 maybe made of flexible metal material that can be flexed out and over thetop of the mobile device 3602, but when pressure is taken off the clip3608, the clip 3608 closes back to clamp against the mobile device 3602.Other embodiments may include types of clips, such as a clip including awound spring that extends when the clip is squeezed and retracts toclamp onto the mobile device 3602.

Referring now to FIG. 37, there is illustrated a mobile device 3702coupled to a colorimetry device 3704 via a charging port 3706 of themobile device 3702. The colorimetry device include a lighting apparatus3708 situated at a first end of the colorimetry device 3704 and disposedto emit light in the same direction as a lens 3710 faces of the mobile3702. At a second end of colorimetry device 3704 is a charging portconnector 3712 configured to plug into the charging port 3706 of themobile device 3702. The colorimetry device 3704 is supplied power viathe charging port 3706 to operate the lighting apparatus 3708. Thisallows for the lens 3710 to either be free of any attachments, or for anattachment to be used over the lens 3710 at the same time as thelighting apparatus 3708, such as applying a colored filter over the lens3710 at the same time as the colorimetry device 3704 is being used, toutilize both white or colored light and a colored filter at the sametime.

Referring now to FIGS. 38A and 38B, there is illustrated a light boxapparatus 3800. FIG. 38A illustrates a top view of the light boxapparatus 3800 and FIG. 38B illustrates a top perspective view of thelight box apparatus 3800. FIG. 38C illustrates the light box apparatus3800 includes a top view of the light box apparatus 3800 in an openstate. FIG. 38D illustrates a side cross sectional view of the light boxapparatus 3800.

The light box apparatus 3800 serves the functions of controlling lightoutside of the light box apparatus 3800, while providing a separatelighting environment within the lighting box apparatus 3800. The lightbox apparatus 3800 has a cubic body 3802 having a substantially hollowinterior. The light box apparatus 3800 may be made of plastic,cardboard, wood, or other materials. In some embodiments, the light boxapparatus 3800 may be provided to a user in a folded or disassembledstate, and the user might configure the box into the position shown inthe accompanying drawings. A top panel 3804 of the light box apparatus3800 includes a window 3806 through which a medical testing device 3808may be viewed. The medical testing device 3808 may be disposed adistance down from the window 3806 and may rest on a platform within thelight box apparatus 3800. The window 3806 may be a clear window, or thewindow 3806 may be a colored filter or film to allow for the filteringof colors when capturing an image of the medical testing device 3808, asdescribed herein. The window 3806 may be made of plastic, glass, orother materials. A user may capture an image of the testing device 3808by either holding a mobile device over the top panel 3804 of the lightbox apparatus 3800, or by placing the mobile device directly over thewindow 3806, in order to use the window as a colored filter, or tominimize light from the environment surrounding the outside of the lightbox apparatus 3800.

Referring now to FIGS. 38C and 38D, FIG. 38C illustrates a top view ofthe light box apparatus 3800 in an open state. FIG. 38D illustrates aside cross sectional view of the light box apparatus 3800. The medicaltesting device 3808 may reside on one or more platforms. As shown inFIG. 38C, the medical testing device 3808 is disposed on two shelves3810 underneath each long edge of the medical testing device 3808. Thetwo shelves 3810 allow for more light to envelope the medical testingdevice 3808 than a solid platform underneath the medical testing device3808 would, since additional light can pass between the two shelves3810.

Light is emitted from one or more lights 3812 disposed below the medicaltesting device 3808 and may sit on or be coupled to an interior bottomof the light box apparatus 3800. The light emitted from the one or morelights 3812 may white light, or colored light. Light is emitted from theone or more lights 3812 up from the bottom of the interior of the lightbox apparatus 3800 towards the top panel 3804 in order to illuminate themedical testing device 3808 from below and envelope the area with light,while avoiding casting light directly on the surface of the medicaltesting device 3808 so that the medical testing device 3808 is nottotally washed out. The one or more lights 3812 may be arranged suchthat the light is spread evenly throughout the light box apparatus 3800,such as shown in FIGS. 38C and 38D, wherein the one or more lights aredisposed at opposite corners of the light box apparatus 3800. The one ormore lights 3812 may also be placed on platforms 3814 extending up fromthe bottom of the light box apparatus 3800, such as shown in FIG. 38D,in order to extend assist in focusing light emitted from the one or morelights towards the top of the light box apparatus 3800.

Referring now to FIG. 39, there is illustrated a light box apparatus3900 including a plurality of lights 3902 in an alternate configuration.The plurality of lights 3902 are arranged such that two lights are eachdisposed near the center of a top and the center of a bottom edge,respectively, of the bottom surface of the light box apparatus 3900, andtwo other lights are each disposed near the center of a left and thecenter of a right edge, respectively, while also residing below thespace between the shelves 3810. This embodiment allows for more light tobe emitted throughout the light box apparatus.

Referring now to FIG. 40, there is illustrated a color wavelengthdetection arrangement 4000. There is illustrated a lighting apparatus4002 directing light in a first wavelength 4004 onto a testing strip4006. The light in the first wavelength 4004 is reflected off thetesting strip 4006 towards a color filter 4008. The light reflected offthe testing strip 4006 may be of a second wavelength 4010 correspondingto the color of the test line and/or the control line and the colorreflected off the test line according to that color of the test line.After passing through the color filter 4008, the light may now be in athird wavelength 4012. The light in the third wavelength 4012 thenreaches the lens 4014 of a mobile device 4016. The lens 4014 may also bea mobile device peripheral or other device for performing colorimeterfunctions.

Different comparisons may be made based on the arrangement 4000. Forexample, the light of the first wavelength 4004 may be compared againstthe light of the third wavelength 4012 to compare how much thewavelength changed between the first introduced light and the lightfinally captured by the lens 4014. The light of the second wavelength4010 may also be compared against the light of the third wavelength4012, to compare the light reflected off the testing strip 4006 againstthe light after being filtered by the color filter 4008.

Referring now to FIG. 41, there is illustrated a color wavelengthdetection arrangement 4100. There is illustrated a lighting apparatus4102 directing light in a first wavelength 4104 through a color filter4106. After passing through the color filter 4106, the light may be in asecond wavelength 4108. The light in the second wavelength 4108 isreflected off a testing strip 4110. The light reflected off the testingstrip 4110 may be of a third wavelength 4112 corresponding to the colorof the test line and/or the control line and the color reflected off thetest line according to that color of the test line, and having alreadybeen filtered by the color filter 4106. The light of the thirdwavelength 4112 then reaches a lens 4114 of a mobile device 4116. Thelens 4114 may also be a mobile device peripheral or other device forperforming colorimeter functions, such as a color sensor peripheralconnected to the mobile device.

The lighting apparatus 4102 may pass white light through the colorfilter 4106, altering the wavelength for use with the arrangement 4100.After the light passes through the color filter 4106, the light of thesecond wavelength 4108 is altered by the color reflecting off the colorof the test line and control line, which creates the third wavelength4112. Since the wavelength produced by a particular color filter may beknown, the captured wavelength (the third wavelength 4112) may becompared to the known second wavelength 4108. The differences betweenthe wavelength and the amount of light absorbed by the color of the testline. The absorbance by the test line may be directly proportional tothe concentration of the bound substance on the test line, indicatingwhether a strong reaction has occurred or not. For example, if thedifference between the wavelengths is small, a weak reaction hasoccurred. However, if there is a large difference between thewavelengths, this may indicate a strong reaction, and thus a highlikelihood of infection or other condition.

Referring now to FIG. 42, there is illustrated a flowchart of a mobiledevice colorimetry analysis process 4200. At step 4202, after selectionof a test to be performed using an application on a mobile device, theapplication issues a reminder of the type of colorimetry device to beused or that is recommended to be used with the selected test, and whatsettings to use for the colorimetry device. For example, the applicationmay suggest using a filter of a particular or to configure a lightingapparatus to emit light of a particular color or colors. At step 4204,the colorimetry device is configured for use with the mobile devicebased on the setting recommended. Step 4204 may also include attachingthe colorimetry device to the mobile device. At step 4206, a camera onthe mobile device is activated and a crosshair indicator and a testingdevice outline appear on the mobile device screen. At step 4208 thecrosshair indicator presented on the screen of the mobile device isaligned with a crosshair icon on the testing device and the deviceoutline presented on the screen of the mobile device is aligned with theborders of a testing device, and, once aligned, an indicator ofsuccessful alignment is presented on the screen and an image of thetesting device is captured by the mobile device camera. At step 4210,the application transmits the captured image to a server.

At step 4212, the server assigns values to the captured test line andcontrol line. The values may correspond to a detected wavelength orother indication of color according to the bound substanceconcentration. The server may additionally store the value of theinitial wavelength of light emitted by a lighting apparatus and used inthe test. The server may also store in association with the test awavelength according to a wavelength of light after having passedthrough a colored filter for the test. At step 4214, the server comparesthe assigned value associated with the test line to the control line andto other data such as the wavelength of the light before encounteringthe control line, or known values from previous tests, either by theuser or other users, etc.

At decision block 4216, it is determined whether the difference betweenthe compared values is above a threshold. For instance, a thresholdvalue may be assigned for the change in wavelength between light castonto the testing device and light reflected off the test line. If thedifference is below the threshold, the process 4200 flows to step 4218,where the server records a negative test result, indicating no infectionor other medical condition. The process then flows to step 4220, wherethe negative result is presented to the user via the mobile deviceapplication. If at decision block 4216 the difference between the valuesis above the threshold, the process flows to step 4222 where the serverrecords a positive result, indicating an infection or other medicalcondition. The process flows from step 4222 to step 4220 to present thepositive test result to the user. The test result provided to the usermay be either a qualitative or quantitative result.

Referring now to FIG. 43, there is illustrated an immunoassay test strip4300 including fluorescent dye indicators 4302. The fluorescent dyeindicators 4302 may be introduced to provide for a fluorescentimmunoassay technique to be applied to the test strip 4300 in order toallow for ratiometric and non-ratiometric analyzation of bound andunbound antibodies, antigens, etc. Various fluorescent dyes areavailable for use, depending on the type of condition being tested, suchas the AF488 or Alexa 488 dye (bright green fluorescent dye). The typeof dye uses is also dependent on whether ratiometric or non-ratiometricanalysis is to be performed. The fluorescent dye or fluorescent compoundmay absorb light or energy (excitation light or energy) at a specificwavelength and then emit light or energy at a different wavelength(emission light or energy). If the antibodies and antigens are bound,the fluorescence of the dye will increase or shift noticeably. Thedifference between the wavelength of the excitation light and theemission light is called the Stokes shift. The greater the shift ordifference in the wavelength the less interference there will be byhaving the excitation light detected as part of the emission light.

The test strip 4300 also includes a conductive electrode sheet 4304coupled to the test line to provide an electric charge to the antibodiesand antigens on the test line during a test. The conductive electrodesheet 4304 may be coupled to a batter 4306 for power. The battery may behoused in a testing device and may provide power for a plurality of teststrips. In other embodiments, the sheet 4304 may a fully functioningelectrode capable of providing a charge without a battery. An electricalcharge may be introduced to provide additional excitation of theantibodies and antigens present on the test line to, which causescertain antibodies or antigens to move towards the charge in order toseparate out molecules, which may be useful in observing bound vs. freemolecules on the test line.

Referring now to FIGS. 44A, 44B, 45A, 45B, and 45C, ratiometric andnon-ratiometric methods of analyzing the results of an immunoassay testmay be performed. In addition to processes described herein, anindicator such as a fluorescent dye may be used in ratiometric andnon-rationmetric measurements. Indicators used for non-ratiometricmeasurements show a shift in fluorescent intensity, with the freeindicator usually having a very weak fluorescence, as illustrated inFIGS. 44A and 44B. As shown in FIGS. 44A and 44B (non-ratiometric), thewavelengths of the free antibodies for both excitation and emissionlight have very low fluorescence intensity, whereas the excitation andemission light of bound antibodies result in high fluorescenceintensity. Non-ratiometric measurements thus are useful in showing astark difference between free and bound subjects, but not as useful formaking minute comparisons.

For ratiometric measurements, such as shown in FIGS. 45A and 45B, boththe excitation and emission light for both free and bound subjects emita high fluorescent intensity. Excitation light on the free and boundsubjects has close result, as shown in FIG. 45A, but the emission lightresults in a shift of the wavelength for the bound subjects, such thatthe bound subjects undergo a color shift, as shown in FIG. 45B, forexample. The changes in color allow for a ratiometric analysis of thetwo emission wavelengths, such as shown in FIG. 45C. This ratio of thefree emission wavelength to the bound emission wavelength may thus beused in analyzing test results of a immunoassay test. If the shift is alarge shift from the free emission wavelength, a strong positive resultfor infection or other medical condition may be indicated.

Referring to FIG. 46, one embodiment of a system device 4600 isillustrated. The system device 4600 is one possible example of a mobiledevice as described herein, a colorimetry device as described herein, orone possible example of a remote server as described herein. Embodimentsinclude cellular telephones (including smart phones), personal digitalassistants (PDAs), netbooks, tablets, laptops, desktops, workstations,telepresence consoles, and any other computing device that cancommunicate with another computing device using a wireless and/orwireline communication link. Such communications may be direct (e.g.,via a peer-to-peer network, an ad hoc network, or using a directconnection), indirect, such as through a server or other proxy (e.g., ina client-server model), or may use a combination of direct and indirectcommunications. It is understood that the device may be implemented inmany different ways and by many different types of systems, and may becustomized as needed to operate within a particular environment.

The system 4600 may include a controller (e.g., a central processingunit (“CPU”)) 4602, a memory unit 4604, an input/output (“I/O”) device4606, and a network interface 4608. The components 4602, 4604, 4606, and4608 are interconnected by a transport system (e.g., a bus) 4610. Apower supply (PS) 4612 may provide power to components of the computersystem 4600, such as the CPU 4602 and memory unit 4604, via a powersystem 4614 (which is illustrated with the transport system 4610 but maybe different). It is understood that the system 4600 may be differentlyconfigured and that each of the listed components may actually representseveral different components. For example, the CPU 4602 may actuallyrepresent a multi-processor or a distributed processing system; thememory unit 4604 may include different levels of cache memory, mainmemory, hard disks, and remote storage locations; the I/O device 4606may include monitors, keyboards, and the like; and the network interface4608 may include one or more network cards providing one or more wiredand/or wireless connections to a network 4616. Therefore, a wide rangeof flexibility is anticipated in the configuration of the computersystem 4600.

The system 4600 may use any operating system (or multiple operatingsystems), including various versions of operating systems provided byMicrosoft (such as WINDOWS), Apple (such as Mac OS X), UNIX, and LINUX,and may include operating systems specifically developed for handhelddevices, personal computers, servers, and embedded devices depending onthe use of the system 4600. The operating system, as well as otherinstructions, may be stored in the memory unit 4604 and executed by theprocessor 4602. For example, the memory unit 4604 may includeinstructions for performing some or all of the methods described herein.

It should be understood that the drawings and detailed descriptionherein are to be regarded in an illustrative rather than a restrictivemanner, and are not intended to be limiting to the particular forms andexamples disclosed. On the contrary, included are any furthermodifications, changes, rearrangements, substitutions, alternatives,design choices, and embodiments apparent to those of ordinary skill inthe art, without departing from the spirit and scope hereof, as definedby the following claims. Thus, it is intended that the following claimsbe interpreted to embrace all such further modifications, changes,rearrangements, substitutions, alternatives, design choices, andembodiments.

What is claimed is:
 1. A system for providing colorimetric andratiometric comparison and quantification for medical test results,comprising: a testing device including thereon an alignment target andincluding a plurality of immunoassay test strips, the plurality ofimmunoassay test strips each including: a sample pad capable ofreceiving a biologic sample; a conjugate pad containing particles forconjugating with antibodies or antigens present in the biologic sample;and a membrane strip including a test line and a control line, whereinthe test line and the control line are viewable; a colorimetry deviceconfigured to operate with a mobile device, wherein the colorimetrydevice includes: one or more light sources configured to emit a firstwavelength of light onto at least the test line of at least one of theplurality of immunoassay test strips, and a color filter disposedbetween the testing device and the mobile device, wherein the colorfilter includes a clamp that presses against a back of the mobile deviceto maintain the color filter over a lens of a camera of the mobiledevice; the mobile device including a viewing screen and a softwareapplication stored thereon, wherein the software application providesexecutable instructions to: receive a selected test from among aplurality of test options; issue a notification concerning use of thecolorimetry device and instructions regarding configuration of thecolorimetry device, for display to a user on the viewing screen, whereinthe notification includes information particular to the selected testand a recommendation for configuring the colorimetry device for use withthe selected test; initiate operation of the camera of the mobiledevice; present on the viewing screen of the mobile device an alignmentgraphic to be aligned with the alignment target of the testing device;detect when an alignment of the alignment graphic and the alignmenttarget has taken place; capture an image of the testing device inresponse to detecting the alignment of the alignment graphic and thealignment target, including receiving, by the camera, a secondwavelength of light, different from the first wavelength of light, thatis passed through the color filter after reflection off the at least oneof the plurality of immunoassay test strips; detect color properties ofa color of the test line and a color of the control line of at least oneof the plurality of immunoassay test strips; transmit the image and thecolor properties to a server; determine a risk value for each of atleast one disease risk tested using the biologic sample, wherein therisk value is a rating determined from the color properties of the colorof the test line; and provide medical test results based on the riskvalue.
 2. The system of claim 1, wherein the colorimetry device includesa light apparatus configured to emit a light of a predefined color ontothe testing device.
 3. The system of claim 1, wherein the colorimetrydevice includes a light box apparatus, wherein the light box apparatusincludes: a body, wherein the one or more light sources are disposedwithin the body; a platform for placing the testing device; and a windowdisposed over the platform on a top panel of the body for viewing thetesting device.
 4. The system of claim 3, wherein the step of capturingthe image includes disposing the mobile device over the window of thelight box apparatus.
 5. The system of claim 4, wherein the window of thelight box apparatus includes the color filter.
 6. The system of claim 1,wherein the software application further provides executableinstructions to: assign values to the first wavelength of light and thesecond wavelength of light; and determine whether a color shift occurredbetween the first wavelength of light and the second wavelength of lightbased on the assigned values.
 7. The system of claim 1, wherein at leastone of the plurality of immunoassay test strips includes one or morefluorescent dye indicators.
 8. The system of claim 1, wherein the testline of one of the plurality of immunoassay test strips includes Zikavirus antigens and the test line of another one of the plurality ofimmunoassay test strips includes an antibodies suitable for binding withhCG.
 9. The system of claim 1, wherein a third wavelength of light isreflected off the at least one of the plurality of immunoassay teststrips and is received by the color filter.